EP2489355A1 - Composition pour la cicatrisation des lésions - Google Patents

Composition pour la cicatrisation des lésions Download PDF

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Publication number
EP2489355A1
EP2489355A1 EP12167804A EP12167804A EP2489355A1 EP 2489355 A1 EP2489355 A1 EP 2489355A1 EP 12167804 A EP12167804 A EP 12167804A EP 12167804 A EP12167804 A EP 12167804A EP 2489355 A1 EP2489355 A1 EP 2489355A1
Authority
EP
European Patent Office
Prior art keywords
formulations
weight
glycine
hydrogen peroxide
hyaluronic acid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP12167804A
Other languages
German (de)
English (en)
Inventor
Gianluca Braguti
Giorgio Delsignore
Margherita Borgonovo
Carlo Introini
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
BMG PHARMA Srl
Original Assignee
BMG PHARMA Srl
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by BMG PHARMA Srl filed Critical BMG PHARMA Srl
Publication of EP2489355A1 publication Critical patent/EP2489355A1/fr
Withdrawn legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/40—Peroxides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
    • A61K31/728—Hyaluronic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like

Definitions

  • compositions including hyaluronic acid and hydrogen peroxide (or other disinfectant substances) and possibly other accelerators of the wound-healing process such as aminoacids, adenosine and plant extracts.
  • the wound-healing process is a complex phenomenon which comprises several stages (inflammation, cell proliferation and tissue reconstruction) involving the epidermis, dermis, extracellular matrix, plasma protein and growth factors.
  • the wound-healing process does not begin if there is an infection secondary to the penetration of pathogenic agents through the damaged skin. It is therefore essential to use molecules with an antimicrobial activity.
  • Hydrogen peroxide is a potent oxidising agent with antibacterial, antiviral and fungicidal power. Hydrogen peroxide is also a metabolite of the immune system, produced by the neutrophil granulocytes as the first response to attack by toxins, parasites, bacteria, viruses and yeasts.
  • oxidising agents and/or sources of oxygen such as sodium perborate, sodium percarbonate, carbamyl peroxide (urea peroxide), potassium permanganate, etc., can be used to reduce the microbe count.
  • disinfectant agents include quaternary ammonium compounds (benzalkonium chloride, benzethonium chloride, chlorhexidine digluconate, polymeric biguanide hydrochloride, etc.), phenol derivatives (dichlorobenzyl alcohol, benzyl chlorophenol, chloromethyl phenol, orthophenyl phenol, etc.), formaldehyde releasers (glutaraldehyde, imidazolidinyl urea, etc.), silver and its salts, mercury derivatives (thiomersal, phenylmercury acetate, etc.), triclosan, bronopol, etc..
  • quaternary ammonium compounds benzalkonium chloride, benzethonium chloride, chlorhexidine digluconate, polymeric biguanide hydrochloride, etc.
  • phenol derivatives diichlorobenzyl alcohol, benzyl chlorophenol, chloromethyl phenol, orthophenyl phenol, etc.
  • wound-healing accelerators examples include hyaluronic acid, aminoacids and plant extracts.
  • Hyaluronic acid is a polysaccharide of the extracellular matrix secreted by the fibroblasts ( Arderson A; Professional Nurse 2001;17:232-235 ). Hyaluronic acid plays a crucial part in the tissue repair mechanisms due to its physico-chemical (hygroscopic, rheological and viscoelastic) and biological properties.
  • Foetal tissues are particularly rich in hyaluronic acid, and are regenerated without scarring after lesions ( W.Y. John, G Abantangelo; Wound repair and regeneration 1999;7:79 ).
  • Hyaluronic acid is also involved in all stages of extracellular tissue repair: at the inflammatory, granulation, re-epithelialisation and wound-healing stages.
  • Hyaluronic acid-based medications have proved more effective than growth factors in promoting wound-healing ( Hu M; J. Biomed. Mater. Res. Appl. Biomater. 2003 15;67(1):586-92 ).
  • aminoacids which promote the wound-healing process are glycine, gamma-aminobutyric acid and arginine.
  • Glycine is an aminoacid which is a basic component of important biological molecules, including collagen. It is a key substance in many metabolic reactions, has anti-inflammatory, cytoprotective and immunomodulating properties, and is the main neurotransmitter with inhibitory activity ( Gundersen Y; Tidsskr Nor Laegeforen. 2004 Mar 18;124(6):773-5 ).
  • Gamma-aminobutyric acid similarly accelerates the restoration of the cutaneous barrier ( Denda M.; J. Invest. Dermatol. 2002 Nov; 119(5):1041-7 ).
  • Arginine the aminoacid precursor of nitric oxide (NO) is not only an important macrophagic mediator of the inflammatory response but also an activator of collagen synthesis at fibroblast level ( Witte M.B.; Am. J. Surg. 2002 183(4):406-12 ).
  • Arginine is also involved in the synthesis of polyamines, which are essential in all DNA duplication processes.
  • the arginases convert arginine into ornithine, the first step in polyamine synthesis. In order for the wound-healing process to take place correctly, there must be a balance between NO and polyamine synthesis.
  • the invention therefore provides topical formulations containing hyaluronic acid and antiseptic agents, preferably hydrogen peroxide alone or in admixture with other antiseptics and optionally aminoacids, adenosine and plant extracts.
  • hyaluronic acid and antiseptic agents preferably hydrogen peroxide alone or in admixture with other antiseptics and optionally aminoacids, adenosine and plant extracts.
  • compositions according to the invention promote the healing of traumatic and post-operative wounds, post-traumatic and diabetic ulcers, bedsores, folliculitis, impetigo and paronychia in diabetic and non-diabetic patients.
  • Hyaluronic acid is preferably present in percentages ranging between 0.01 and 5% in weight, and hydrogen peroxide (120 Vol.) between 1 and 15%.
  • the preferred aminoacids are glycine and/or arginine, each present in percentages ranging between 0.01 and 2% in weight.
  • Adenosine in percentages from 0.01 to 3% further promotes healing and exerts anti-inflammatory action mediated by leukotrienes and TNF.
  • antiseptic agents examples include chlorhexidine, urea peroxide, phenylmercury acetate, o-phenyl-phenol and the like.
  • compositions according to the invention are preferably in the form of aqueous gels or polyalcohols containing thickening polymers such as cellulose derivatives or acrylic polymers, together with other excipients in conventional use, such as preservatives, perfumes and the like.
  • compositions according to the invention are prepared by dissolving hyaluronic acid or one of its salts, and possibly glycine, in deionised water at the first stage.
  • the thickening polymer, if any, and an aqueous solution of any other constituents are then added to the homogeneous solution obtained.
  • Hydrogen peroxide is then added slowly under continuous agitation until a homogenous dispersion is obtained.
  • plant extracts which can be used in the formulations according to the invention are extracts of Ficus bengalensis, Cynodon dactylon, Symplocos racemosa, Rubia cordifolia, Pterocarpus santalinus, Ficus racemosa, Glycyrrhiza glabra, Berberis ristata, Curcuma longa, Dentella asiatica, Euphorbia nerifolia and Aloe vera.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Engineering & Computer Science (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Molecular Biology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Medical Informatics (AREA)
  • Biotechnology (AREA)
  • Botany (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Cosmetics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
EP12167804A 2005-08-11 2006-08-03 Composition pour la cicatrisation des lésions Withdrawn EP2489355A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT001569A ITMI20051569A1 (it) 2005-08-11 2005-08-11 Composizione cicatrizzante
EP06776586.7A EP1948200B1 (fr) 2005-08-11 2006-08-03 Composition pour la cicatrisation des lesions

Related Parent Applications (2)

Application Number Title Priority Date Filing Date
EP06776586.7A Division EP1948200B1 (fr) 2005-08-11 2006-08-03 Composition pour la cicatrisation des lesions
EP06776586.7A Division-Into EP1948200B1 (fr) 2005-08-11 2006-08-03 Composition pour la cicatrisation des lesions

Publications (1)

Publication Number Publication Date
EP2489355A1 true EP2489355A1 (fr) 2012-08-22

Family

ID=37306522

Family Applications (2)

Application Number Title Priority Date Filing Date
EP06776586.7A Active EP1948200B1 (fr) 2005-08-11 2006-08-03 Composition pour la cicatrisation des lesions
EP12167804A Withdrawn EP2489355A1 (fr) 2005-08-11 2006-08-03 Composition pour la cicatrisation des lésions

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP06776586.7A Active EP1948200B1 (fr) 2005-08-11 2006-08-03 Composition pour la cicatrisation des lesions

Country Status (8)

Country Link
US (1) US20090074879A1 (fr)
EP (2) EP1948200B1 (fr)
DK (1) DK1948200T3 (fr)
ES (1) ES2643300T3 (fr)
IT (1) ITMI20051569A1 (fr)
PL (1) PL1948200T3 (fr)
PT (1) PT1948200T (fr)
WO (1) WO2007017176A1 (fr)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2078528B1 (fr) 2006-09-22 2013-08-14 Kochi University Sensibilisateur de rayonnement ou sensibilisateur de chimiothérapie
DE102007034639A1 (de) * 2007-07-23 2009-01-29 Antiseptica Chemisch-Pharmazeutische Produkte Gmbh Mehrteiliges Medizinprodukt
EP2226073A1 (fr) * 2009-03-02 2010-09-08 Euro-Celtique S.A. Composition pharmaceutique topique renfermant un agent antiseptique et de l'arginine pour la cicatrisation des plaies
KR20110048671A (ko) * 2009-11-03 2011-05-12 엘지전자 주식회사 단백질 활성 억제제를 포함하는 공기 정화 필터, 및 이의 제조방법
CZ22394U1 (cs) * 2011-03-11 2011-06-20 Contipro C, A.S. Antimikrobiální smes a kryt pro podporu hojení ran s antimikrobiálním úcinkem
US9439940B2 (en) * 2011-07-19 2016-09-13 Neville Pharmaceutical, Inc. Topical transdermal method for delivering nutrients through the skin for expeditied wound healing and skin rejuvenation
US10166260B2 (en) * 2013-05-24 2019-01-01 Blaine Laboratories, Inc. Wound care product with egg shell membrane
EP3212204B1 (fr) 2014-10-28 2019-07-03 Biovotec AS Particules de membrane de coquille d'oeuf micronisée et leur utilisation pour favoriser la cicatrisation des plaies
US11045578B2 (en) 2015-06-24 2021-06-29 Biovotec As Tissue engineering scaffolds comprising particulate egg shell membrane
GB201519923D0 (en) 2015-11-11 2015-12-23 Biovotec Dac And Biovotec As Dry biocompatible disintegrateable films for delivering particulate egg shell membrane to a wound
IT201600108848A1 (it) * 2016-10-27 2018-04-27 Giuliani Spa Composizioni dermatologiche
US20190053495A1 (en) * 2017-08-20 2019-02-21 Bruce Smyth Polymeric topical antiseptic compound and method of use
IT202000016984A1 (it) 2020-07-13 2022-01-13 Bmg Pharma S P A Composizioni igienizzanti e antiinfettive per le mucose orali
IT202100023921A1 (it) * 2021-09-21 2023-03-21 Casadei Elena Francesca Composizione per il trattamento analgesico e riepitelizzante del tessuto vulvo-vaginale e perineale.

Citations (5)

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Publication number Priority date Publication date Assignee Title
EP0480189A1 (fr) * 1990-10-05 1992-04-15 Altergon S.A. Composition pharmaceutique à usage topique contenant du sel de sodium de l'acide hyaluronique et des désinfectants
JPH04134036A (ja) * 1990-09-21 1992-05-07 Meiji Seika Kaisha Ltd 擦式手指消毒用医薬品組成物
JP2000319171A (ja) * 1999-03-03 2000-11-21 Nof Corp 殺菌性皮膚外用剤組成物
WO2005007174A2 (fr) * 2003-07-07 2005-01-27 Karagoezian Hampar J Preparations ophtalmiques antimicrobiennes synergetiques et dermatologiques contenant du chlorite et du peroxyde d'hydrogene
WO2006053164A2 (fr) * 2004-11-09 2006-05-18 Advanced Medical Optics, Inc. Solution ophthalmique

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US4607101A (en) * 1981-08-27 1986-08-19 Jaye-Boern Laboratories, Inc. Method of treating acne vulgaris with a composition containing carbamide peroxide
WO1996003158A1 (fr) * 1994-07-22 1996-02-08 Alcon Laboratories, Inc. Utilisation d'acides amines de faible poids moleculaire dans des compositions ophtalmiques
US6673374B2 (en) * 1998-07-31 2004-01-06 Howard Murad Pharmaceutical compositions and methods for managing skin conditions
US6592907B2 (en) * 1999-10-04 2003-07-15 Hampar L. Karagoezian Synergistic antimicrobial ophthalmic and dermatologic preparations containing chlorite and hydrogen peroxide
US6624203B1 (en) * 2001-11-08 2003-09-23 Francis X. Smith Nucleic acid bases used in ophthalmic solutions

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH04134036A (ja) * 1990-09-21 1992-05-07 Meiji Seika Kaisha Ltd 擦式手指消毒用医薬品組成物
EP0480189A1 (fr) * 1990-10-05 1992-04-15 Altergon S.A. Composition pharmaceutique à usage topique contenant du sel de sodium de l'acide hyaluronique et des désinfectants
JP2000319171A (ja) * 1999-03-03 2000-11-21 Nof Corp 殺菌性皮膚外用剤組成物
WO2005007174A2 (fr) * 2003-07-07 2005-01-27 Karagoezian Hampar J Preparations ophtalmiques antimicrobiennes synergetiques et dermatologiques contenant du chlorite et du peroxyde d'hydrogene
WO2006053164A2 (fr) * 2004-11-09 2006-05-18 Advanced Medical Optics, Inc. Solution ophthalmique

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ARDERSON A, PROFESSIONAL NURSE, vol. 17, 2001, pages 232 - 235
BISWAS ET AL., INT. J. LOW EXTREM. WOUNDS, vol. 2, no. 1, 2003, pages 25 - 29
DATABASE MEDLINE [online] US NATIONAL LIBRARY OF MEDICINE (NLM), BETHESDA, MD, US; 2001, YAMASHINA S ET AL: "Endothelial cells contain a glycine-gated chloride channel.", XP002408255, Database accession no. NLM11962256 *
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DENDA M ET AL: "Gamma-Aminobutyric acid (A) receptor agonists accelerate cutaneous barrier revocery and prevent epidermal hyperplasia induced by barrier disruption", JOURNAL OF INVESTIGATIVE DERMATOLOGY, NEW YORK, NY, US, vol. 119, no. 5, November 2002 (2002-11-01), pages 1041 - 1047, XP002966358, ISSN: 0022-202X *
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DENDA MITSUHIRO ET AL: "Influx of calcium and chloride ions into epidermal keratinocytes regulates exocytosis of epidermal lamellar bodies and skin permeability barrier homeostasis.", THE JOURNAL OF INVESTIGATIVE DERMATOLOGY. AUG 2003, vol. 121, no. 2, August 2003 (2003-08-01), pages 362 - 367, XP002407248, ISSN: 0022-202X *
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HU MIN ET AL: "Three-dimensional hyaluronic acid grafts promote healing and reduce scar formation in skin incision wounds.", JOURNAL OF BIOMEDICAL MATERIALS RESEARCH. PART B, APPLIED BIOMATERIALS. 15 OCT 2003, vol. 67, no. 1, 15 October 2003 (2003-10-15), pages 586 - 592, XP009074775, ISSN: 1552-4973 *
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W.Y. JOHN; G ABANTANGELO, WOUND REPAIR AND REGENERATION, vol. 7, 1999, pages 79
WITTE M.B., AM. J. SURG., vol. 183, no. 4, 2002, pages 406 - 12
WITTE MARIA B ET AL: "Role of nitric oxide in wound repair.", AMERICAN JOURNAL OF SURGERY. APR 2002, vol. 183, no. 4, April 2002 (2002-04-01), pages 406 - 412, XP002407249, ISSN: 0002-9610 *
YAMASHINA S., NUTR. CANCER, vol. 40, no. 2, 2001, pages 197 - 204

Also Published As

Publication number Publication date
ITMI20051569A1 (it) 2007-02-12
PT1948200T (pt) 2017-10-19
DK1948200T3 (en) 2017-10-02
WO2007017176A8 (fr) 2008-05-08
ES2643300T3 (es) 2017-11-22
PL1948200T3 (pl) 2017-12-29
EP1948200A2 (fr) 2008-07-30
EP1948200B1 (fr) 2017-07-19
WO2007017176A1 (fr) 2007-02-15
US20090074879A1 (en) 2009-03-19

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